Bioengineer III / Assistant Vaccine Managers - Goldbelt, Inc.

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices. 

Summary:

Goldbelt Apex LLC is seeking a Bioengineer with a unique opportunity to support our esteemed client, the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS), at our Ft. Detrick, MD location. We are particularly interested in candidates with an active Secret clearance, and only those eligible for a Secret-level clearance will be considered (US Citizenship required).

Essential Job Functions:

• Serve as the technical representative on project teams, supporting risk planning efforts and providing advice and assistance in implementing product process improvements.
• Serve on internal and external integrated product teams (IPTs), responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items.
• Participate in contractor site visits, assist in monitoring performance and regulatory and quality standards, and provide technical oversight during production/manufacturing.
• Serve as the programmatic representative at conferences and stakeholder meetings.
• Provide technical knowledge to guide the product team through corrective/preventative actions.
• Collaborate with project teams and participate in evaluating technical results in multiple developmental areas, developing strategies to move the program forward.
• Collaborate with internal and external partners and research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
• Provide periodic update reports to Product Managers (PMs).
• Assist the PMs in assessing cost and schedule risks and developing mitigation strategies.
• Develop drafts, review, and provide edits/comments on technical documentation (e.g., development/technology transition agreements and standard operating procedures).
• Prepare and review draft protocols and study plans about various developmental efforts (assay development), providing feedback supporting advanced development efforts.
• Prepare documentation/presentations summarizing technical results, including displaying results in “Layman’s” terms, formulating conclusions, and developing technical strategies in response to the data outcomes.
• Review and search scientific literature and databases to identify technical information and provide references to support product development efforts.
• Assist in identifying and assessing risks of new technologies and ongoing projects.
• Prepare briefing materials.
• Provide technical oversight and project management support, acquisition program strategic planning, contract guidance, and advisory services for DBPAO commodities with little supervision.
• Serve as a subject matter expert on all program quality initiatives (e.g., internal and external International Standards Organization (ISO) accreditations, existence and completeness audits, quality assurance, quality control, etc.).
• Develop product test protocols (i.e., validation studies, stability studies, sampling plans with traceability to statistic models, and Defense Biological Product Assurance Office (DBPAO) assay design packages).
• Provide technical input to acquisition documents and presentations supporting program reviews or other program presentations.

Necessary Skills and Knowledge:

• Possess strong analytical, problem-solving, and organizational skills to balance and prioritize work.
• Possess strong interpersonal and communication skills, both oral and written.
• Maintain interpersonal contacts to increase effective team dynamics; effectively communicate ideas, requirements, and scientific knowledge across and within organizations united to develop medical countermeasures.
• Possess five years of working experience with Microsoft Office, including Outlook, Project, PowerPoint, Excel, and Word.
• Possess sufficient experience in using Microsoft Projects and Microsoft Excel to provide a level of proficiency that allows independent development and management of resource-loaded Integrated Master Schedules (IMSs) and financial documents.

Minimum Qualifications:

• Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience.
• Possess DAU Level I equivalency in Program Management or senior-level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process). Rest assured, DAU courses will be at government cost; however, travel costs (e.g., per diem, lodging, mileage) will not be government cost.
• Possess five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
• Possess five (5) years of project management experience in cost, schedule, performance, risk analysis, and advice.
• Possess experience in portfolio management of pharmaceutical/biotechnology drug development (i.e., investment decisions based on the risk management process).
• Possess extensive customer support/relations experience.
• Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

Preferred Qualifications:

• Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as eight (8) years of general experience and five (5) years of relevant experience.

The salary range for this position is $75,000 to $115,000 per year.

Pay and Benefits
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.